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LEADER IN INFECTION CONTROL SOLUTIONS Addressing the need for safer, faster and eco-friendly high level disinfection of ultra sound probes For personal use only
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For personal use only - ASX · 2013. 5. 6. · − FDA communication ... Q4 FY11 Q1 FY12 Q2 FY12 Q3 FY12 Q4 FY12 Q1 FY13 Q2 FY13 Q3 FY13 Expanded US sales team GE contract For personal

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Page 1: For personal use only - ASX · 2013. 5. 6. · − FDA communication ... Q4 FY11 Q1 FY12 Q2 FY12 Q3 FY12 Q4 FY12 Q1 FY13 Q2 FY13 Q3 FY13 Expanded US sales team GE contract For personal

LEADER IN INFECTION CONTROL SOLUTIONS Addressing the need for safer, faster and eco-friendly high level

disinfection of ultra sound probes

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Disclaimer

This presentation is intended to provide a general outline only and is not intended to be a definitive statement on the subject matter. The information in this presentation, whether written or verbal, has been prepared without taking into account the commercial, financial or other needs of any individual or organisation. Certain information may relate to protected intellectual property rights owned by Nanosonics (the “Company”). While Nanosonics has taken due care in compiling the information, neither the Company nor its officers or advisors or any other person warrants the accuracy, reliability, completeness or timeliness of the information or guarantees the commercial or investment performance of the Company. The information does not constitute advice of any kind and should not be relied on as such. Investors must make their own independent assessment of the Company and undertake such additional enquiries as they deem necessary or appropriate for their own investment purposes. Any and all use of the information is at your own risk.

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Nanosonics Highlights

Developed proprietary automated system for low temperature, high level disinfection

First product, trophon®

EPR for disinfection of ultra sound probes

trophon EPR approved for sale in major western markets (incl. US)

Achieved significant market penetration in Australia (>30%)

GE Healthcare exclusive distributor in North America

Revenue increased from A$2.2m to A$12.3m in 1st year of North American launch (FY12)

Accelerating sales in North America and expanding to other regions

Strong Balance Sheet – cash A$24.9m as at March 2013

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Investment Thesis

Advancing global rollout of trophon®

EPR – the first fully automated system for high level

disinfection of ultra sound probes

Addresses unmet market need: current disinfection methods are antiquated, manual,

dangerous and inefficient

Strong regulatory, legal liability and economic drivers for adoption

Significant, global market > addressable market for device in US alone worth $400M

Attractive business model > up front sale and ongoing revenue from consumables and service

trophon®

EPR rapidly achieving market adoption: “Standard of Care”

− ~A$10m revenue in North America in first full year of sales (FY12)

− Several leading sites have already adopted

Pipeline of further product development opportunities – core patents until 2025 For

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Our Technology – Nano-nebulisation for Low

Temperature Disinfection

High frequency sonic vibration turns disinfecting

liquid into nano-sized droplets

Nano droplets disperse like a gas

− Covers entire surface of object being

disinfected

Nano-nebulant is a strong oxidising agent

− Lethal to bacteria, viruses and fungi

Nano-nebulant evaporates

− Surface of disinfected object left dry and

ready to use

Non-toxic by-products

− Water and oxygen

Patent to 2025

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High Level Disinfection Methods

Disinfection processes

unchanged in 20+ years

Existing methods have

many shortfalls

Autoclave (High Pressure / High Temperature

Disinfection)

− Standard high level disinfection method

− Not an option from many disinfection requirements

− Heat / pressure destroys electrical equipment or

sensitive environments

Chemical Soak

− Uses highly toxic chemicals

− Often corrosive to equipment

− Hazardous to users

Spray / Wipe

− Crude and ineffective

− High risk of on-going infection

Unchanged for 20+ years

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Lead Product –trophon EPR

Rapid

− Fully automated 7 minute disinfection cycle

Safe

− Self contained

− Non-toxic chemistry

Gentle / non-damaging to probe

Effective

− In-built checking systems

− Disinfects entire probe

Convenient / Efficient

− Small size – point of care

− Compatible with all makes of probes

− Saves time, infrastructure and cost

Low temperature high level disinfection for intra-cavity ultrasound probes

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Multiple factors driving adoption and “Standard of Care”

Regulatory

− Compliance to 2008 US CDC Guidelines for disinfection / sterilisation

− FDA communication – probe must be completely immersed for effective high level

disinfection

Safe & appealing workplace

− Removes workplace exposure to hazardous chemicals

Focus on reducing Hospital Acquired Infections (HAI)

− Key metric of hospital performance

− Hospitals bear the additional cost of treating patients for HAI

Compelling economics

− Increased revenue

− Improved patient throughput due to availability of probes

− Decreased costs

− OH&S and HAI savings

− Preserves life of probes

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Large and Accessible Market

USA addressable install base: ~40,000 trophon EPR

− Equivalent sized markets in both Europe and RoW

Current end sale price ~ US$10,000 per unit

− average consumables ~ $3,000pa

− additional revenue from service contracts and

accessories

− estimated user life 4 – 5 years

− line extensions and modifications in development

Main customer groups

− Sonographers (medical imaging specialists)

− Hospitals (emergency and surgical)

− Obstetricians and gynecologists

30%

36%

34%

North America Europe ROW

Distribution of ultrasound machines globally

Siemens 17%

Toshiba 14%

Hitachi, Aloka. Medison etc

24%

Philips 21%

GE Healthcare

24%

Ultrasound Manufacturer Market Share

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Established Sales and Distribution

North

America

South

America

Africa

Europe

Asia

Middle East

Australia

United

Kingdom

Central

America

Approved for sale in the US and most other

major western markets

Approved in Major Western Markets Multiple Channels to Market

Exclusive North American distribution with GE

Healthcare

− ~30% ultrasound share in North America

Toshiba signed (April 2013) as non-exclusive

distribution partner in UK

Multiple distributors: Europe, Australia, Asia

and New Zealand

Recent investment in direct sales and

distribution sales support in North America

and Europe to further accelerate market

penetration

Japan

Key to global distribution

GE Healthcare – exclusive distributor

GE Healthcare – non exclusive distributor

Toshiba

Other distributors

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Attractive Revenue Model

Trophon

Accessories Consumables

Service &

maintenance

contracts

35% 5% 45% 15%

Multiple revenue streams: Up-front sales plus consumables, accessories and

service contracts

Each unit sale results in robust annuity type revenue streams moving forward

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Revenue $A'000 Year 1 Year 2 Year 3 Year 4 Total

Trophon 10.0 10.0

Consumables

Sonex 3.0 3.0 3.0 3.0 11.9

Chemical Indicator 0.3 0.3 0.3 0.3 1.4

3.3 3.3 3.3 3.3 13.3

Accessories

Cart (or Wall Mount) 1.4 1.4

Printer 0.8 0.8

Software 0.7 0.7

2.8 2.8

Service - 1.4 1.4 1.4 4.1

Total Annual Revenue Potential 16.1 4.7 4.7 4.7 30.1

Average GM% 77% 87% 87% 87% 81%

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trophon® EPR Lifecycle Revenue Example F

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Adoption in Key Markets

Australia and New Zealand

Established strong market penetration in own domestic market

Good take up from major medical imaging providers such as I-Med

Europe and Asia

European adoption previously hampered by disparate distribution arrangements

Targeting a more focused approach into select European and Asian markets

North America

GE launched trophon®

EPR in July 2011

Approximately A$10m revenue in North America in 1st year launch (FY12)

Many leading sites have already adopted

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North American Sales Leading the Way

North America

83%

ANZ 13%

Rest of the world 3%

Revenue by Market North American IB Growth Trajectory

Installed base

1st US shipment

GE Incentive Scheme updated

Dedicated BD Manager and US sales consultant hired

trophon® EPR entered Canadian Market

Q4 FY11 Q1 FY12 Q2 FY12 Q3 FY12 Q4 FY12 Q1 FY13 Q2 FY13 Q3 FY13

Expanded US sales team

GE contract signed

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Several Major Sites Already on Board

Institution Units Location

SCRIPPS CLINIC (multiple sites) 21 California, CA

BRIGHAM AND WOMAN’s 21 Boston, MA

MASSACHUSETTS GENERAL 26 Boston, MA

JOHNS HOPKINS 20 Baltimore, MD

BETH ISRAEL DEACONESS MEDICAL CENTER INC 38 Boston, MA

WALTER REED NATIONAL MILITARY MEDICAL CENTER 8 Bethesda, MD

MONTEFIORE MEDICAL CENTER - EINSTEIN DIVISION 23 Bronx, NY

KAPIOLANI MEDICAL CENTER FOR WOMEN & CHILDREN 11 Honolulu, HI

ALBERT EINSTEIN MEDICAL CENTER 6 Philadelphia, PA

MOUNT SINAI HOSPITAL 8 New York, NY

CALGARY RADIOLOGY 52 Calgary, Canada For

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Strong Customer Satisfaction to Date

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Successful “Try it and Buy it Program”

− 80+ sites trialled

− An average of 2.5 units sold per unit trialled

What the market is saying about trophon:

EFFICIENT: Independent cost / benefit analysis concludes trophon® EPR is

more efficient and easy to use – saves 7.5 hours per week

SAFE: “Trophon® EPR has answered our OH&S concerns – our staff are no

longer exposed to hazardous fumes (Sydney IVF)

EFFECTIVE: “It’s a whole new feeling of clean” (South Georgia Medical

Centre, US)

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Platform for Future Growth Utilising our strong IP position to develop extended applications for our

disinfection technology

− R&D team of 8 people

− FY13 A$2m-A$3m budget on new product development

− ENT market and TEE (Trans oesophageal Echocardiography) probes

− Investigation of expanded application for NanoNebulant

Leverage our early success in local or North American markets to establish

trophon in other major regions

Europe

− Combination of improved distribution and direct sales capability

− UK and France immediate focus

− Toshiba appointed (April 2013) as non-exclusive distributor in the U.K

Asia

− Build on HK Hospital Authority Approval

− Preparing for Singapore launch

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FY13 Priorities / Upcoming milestones

Leverage investment in sales resources by NAN, GE and Toshiba to accelerate

growth in key markets of North America and Europe

Maximise penetration in home market – Australia and New Zealand

Build on early momentum in Hong Kong; launch in Singapore

Actively pursue Key Opinion Leader engagement and capitalise on regulatory

opportunities in Europe

Obtain additional regulatory approvals, in particular in Asia

Identify new product opportunities

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APPENDICES

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Capital Structure and Register

As of March 31, 2013 (all figures in AUD)

Shares on issue ~261.6 million shares

Market capitalisation ~$120 million

Cash balance $24.9 million

Average daily trading volume (12 months) 0.188 million shares

Institutions 31%

Corporate 4%

Private Investors &

Others 37%

Founders and Related

Parties 28%

Share register breakdown Substantial shareholders %

Mr Bernard Stang 10.97%

Mr Maurie Stang 10.87%

Alan Gray Australia Pty Ltd 10.46%

Mr Steve Kritzler 7.52%

Kinetic Investment Partners Limited 7.26%

Fisher Funds Management Limited 6.65% For

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Recent Financial Performance

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A$’000s 2010 2011 2012

Operating Revenue 763 2,247 12,301

% Change y-o-y 147% 194% 447%

Cost of Sales (284) (981) (4799)

Gross Profit 479 1,266 7,502

Over Income - Government Grants 161 – 150

Operating Expenses (8,827) (13,229) (12,634)

% Change y-o-y -11% 50% -4%

EBITDA (8,187) (11,963) (4,982)

% Change y-o-y -14% 46% -58%

D&A (771) (1,010) (914)

EBIT (8,958) (12,973) (5,896)

% Change y-o-y -10% 45% -55%

Interest Income 785 1,052 586

PBT (8,173) (11,921) (5,310)

Net Income Tax Benefit – 707 631

NPAT (8,173) (11,214) (4,679)

% Change y-o-y -7% 37% -58%

Cash and Cash Equivalents 21,144 12,356 29,310

% Change y-o-y 52% -42% 137%

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Company History – Major Events

2001: Founded to develop

or commercialise nano-

nebulant technology for

low temperature

disinfections

Apr 2008: Trophon

CE mark certification

May 2007: Listed

on ASX

Feb 2009: Trophon TGA

approval certification

Mar 2009: First

Trophon sales to

Australian market

Feb 2011: Trophon

FDA approved

May 2011: Exclusive

North American

distribution with GE

Jul 2011: North

American launch

Dec 2011: Expanded

manufacturing capacity

50% to 6000 units / year

Jun 2012: GE A$7.5m

convertible note

investment

Jun 2012: A$10m+

North American revenue

in 1st year of launch

2001 2009 2012 2011

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Executive Team

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Ron Weinberger

CEO and Executive Director

Joined the company in August 2004 and was appointed Managing Director and CEO in December 2011

Co-inventor of several key Nanosonics’ inventions which underpin the company’s technology platform

Has a PhD in medical research and over two decades experience in biotechnology

McGregor Grant

CFO and Company Secretary

Joined Nanosonics in April 2011

15 years’ experience in senior roles in medical device and healthcare industries in Australia and the US

Previously worked for Coopers & Lybrand in Australia and Europe

Michael Potas

Head of RD&D

Joined Nanosonics in August 2006

More than 16 years’ experience in the development and commercialisation of new products and technologies

Instrumental in the research, design & development of the Trophon®

EPR

Gerard Putt

Head of Manufacturing

Joined Nanosonics full time in April 2011 after 18 months on the Nanosonics advisory board

Over 12 years’ experience in the Medical Device industry as a leader of development, engineering and

production teams at ResMed

Vincent Wang

Head of Global Services

Over 11 years’ experience in in global medical device markets

Previously worked for Sonova Hearing Healthcare Group and as Regional Technical Service and Repair

Manager for Cochlear

Ronald J Bacskai

President & CEO,

Nanosonics Inc

Joined Nanosonics in 2010 and is responsible for supporting Nanosonics’ operations in the United States

Extensive experience in marketing & sales and technology commercialisation in a number of different

industries

Jianhe Chen

Quality Assurance Manager

9 years’ experience in quality assurance and regulatory affairs in globalised medical device companies

Specialises in establishing, developing and maintaining the quality management systems for medical device

manufacturers

Has held senior leadership roles in various international medical device companies in the past 11 years

Ruth Cremin

Regulatory Affairs Manager

Joined Nanosonics in June 2011 and has extensive regulatory affairs experience

Previously Senior Regulatory Affairs Specialist at Cochlear for the Asia Pacific Region, and also regulatory

and quality roles at Pfizer and Bio-Medical Research

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Board of Directors

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Maurie Stang

Non-Executive Chairman

Appointed Non-Executive Chairman March 2007, Director since 2000

Entrepreneur with over 20 years of experience in building and managing companies in the healthcare and

biotechnology sector

Currently Non-Executive Chairman of Aeris Environmental Ltd. Owns 28.7M shares (10.9%) of Nanasonics

Ron Weinberger

CEO and Managing

Director

Joined the company in August 2004 and was appointed Managing Director and CEO in December 2011

Co-inventor of several key Nanosonics’ inventions which underpin the company’s technology platform

Has a PhD in medical research and over two decades experience in biotechnology

Richard England

Non-Executive Director

Chartered Accountant with over 30 years experience in accounting and financial services

Previously was Chairman of Gropep, and Director of ITL Ltd

Outside of the life sciences, Mr England has previously been Chairman of Ruralco Holdings and Chairman of

Chandler Macleod

David Fisher

Non-Executive Director

Over 25 years' experience in the biotechnology and healthcare industry in Australia and overseas

Founding partner of Brandon Capital Partners, a leading venture capital firm which specialises in

investments in the Life Sciences sector

Previously CEO of Peptech, which was acquired by US-based Cephalon, and Pharmacia, which is now part

of Pfizer

Michael Kavanagh

Non-Executive Director

Over 20 years’ experience in healthcare marketing

Currently Senior Vice President of Global Marketing for Cochlear which he has held for more than 9 years

Currently has no other directorship For

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